Indocyanine Green Fluorescence During Fundus First Laparoscopic Cholecystectomy

Not Applicable

Not yet recruiting

• Conditions: Gallstone; Gallstone; Cholecystitis, Acute

• Registration Number: NCT06918210
• Lead Sponsor: Karolinska Institutet

Brief Summary

Laparoscopic cholecystectomy is the routine method for managing gallstone disease. This is considered a safe procedure with low risk of severe complications. Lesions to the deep bile ducts is, however, a rare complication from laparoscopic cholecystectomy that may have devastating consequences. The risk of bile duct injuries may be reduced by adapting the surgical approach. In general, the operation is started from the lower part of the gallbladder and continued upwards. It may, however, also be initiated from the top of the gallbladder and extended downwards. This approach, also termed fundus first, is routine at a few units.

By injecting Indocyanin Green (ICG) that is excreted into the bile, the bile ducts may be visualized using near infrared light. This is a technique for mapping the anatomical structures adjacent to the gallbladder that has been used in previous studies for preventing bile duct injuries. This method has, however, not been tested at units where fundus first is the routine surgical technique. In the present randomized controlled trial, the investigators intend to evaluate the safety of ICG as a means for reducing the risk of bile duct lesions and to see if it works as intended.

Altogether 294 operations for gallstones will be included in the study. The patients will be randomized to surgery with or without ICG. Regardless of the randomization, all operations will be undertaken with the fundus first technique.

Thirty days after the operation, all data related to the operation are retrieved from the patient records by an assessor that does not know what group the patient was randomized to. The primary endpoint of the study is the time required from the start of the operation until intraoperative cholangiography is done. In addition, total operative time, all surgical complications and need for converting the operation to an open procedure will be recorded.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-27
• Study First Submitted QC: 2025-04-05
• Last Update Submitted: 2025-04-05
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-09
• Study Start: 2025-08-01
• Primary Completion: 2027-07-31
• Study Completion: 2028-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

• Patients undergoing laparoscopic cholecystectomy
• Verbal and written consent provided
• Age ≥ 18 years

Exclusion Criteria

• Thyroid disease
• Allergy against ICG or Iodine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to intraoperative cholangiography	During procedure.	Time from first incision until intraoperative cholangiography

Secondary Outcome Measures

Name	Time	Method
Procedure-related complications	Up to 30 days postoperatively	Complications related to the cholecystectomy confirmed intraoperatively or postoperatively
Total operative time	During procedure	Time from first incision to closure of the wounds
Intraoperative gallbladder perforation	During procedure	Intraoperative iatrogenic gallbladder perforation
Conversion from laparoscopic to open cholecystectomy	During procedure	Decision to convert from laparoscopic to open cholecystectomy taken intraoperatively
Surgeon perception of complexity	During procedure	The perception of the complexity of the procedure rated by the surgeon on a numeric rating scale from 0 to 10 where 10 indicates the highest level of complexity
Patient reported outcome	Up to 30 days postoperatively	Symptoms and satisfaction rated by the patient 30 days postoperatively on a numeric rating scale from 0 to 10 where 10 indicates the highest level of satisfaction and absence of symptoms